FDA Wants More Data on GSK Drug
Posted on: Monday, 11 June 2007, 12:00 CDT
GlaxoSmithKline and Adolor said the U.S. Food and Drug Administration requested more data on Entereg, a possible post-operative ileus treatment.
The FDA also put Entereg's investigational new drug applications on clinical hold until the requested data is submitted.
The companies submitted a response last November to the FDA's approvable letter for Entereg, but the agency said it wants more data, including the final results of Study 101684, an extension of the Phase 2b Study 008 and further analysis of results from Study 014.
The FDA also requested final results of two-year cancer studies in rats and mice and safety data from Study 228.
We are working closely with GSK to complete analyses of these studies and satisfy all requests for data for our complete response, said Michael R. Dougherty, Adolor's president and chief executive officer. We now expect that this submission will occur in the third quarter of 2007.
Source: United Press International
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